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AVANOS 42-9368Recalls & reported problems

Avanos Medical, Inc. · CORFLO* Nasogastric/Nasointestinal Feeding Tube with Stylet with ENFit® Connector · Class 2

Quick summary

This Avanos CORFLO feeding tube delivers nutrition and medicine through the nose into the stomach. The 35 reports mostly describe the tube puncturing, cracking or splitting, blocking completely so nothing can pass, and leaking near the port; some mention it breaking during flushing and fragments left in the patient. Reports describe 2 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
37
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00350770460925), received between Feb 28, 2020 and Sep 9, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 2 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 2 reportsFeb 2026: 2 reportsMar 2026: 3 reportsApr 2026: 0 reportsMay 2026: 6 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Puncture/Hole11
  • Break8
  • Complete Blockage7
  • Leak/Splash7
  • Material Rupture6
  • Material Split, Cut or Torn4
  • Fracture3
  • Fluid/Blood Leak2

Patient problems

  • No Clinical Signs, Symptoms or Conditions19
  • Foreign Body In Patient8
  • Feeding Problem5
  • Cough4
  • Aspiration/Inhalation2
  • No Consequences Or Impact To Patient2
  • Respiratory Tract Infection1
  • Vomiting1

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 9, 2026Leak/Splash; Material Rupture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50699920 ↗
  • MalfunctionSep 9, 2026Material Rupture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50699918 ↗
  • MalfunctionJun 29, 2026Complete Blockage; Material Rupture

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00513 FOR THE SECOND REPORT. IT WAS REPORTED THAT NURSING STAFF WERE ADMINISTERING MEDICATION THROUGH THE NASOGASTRIC FEEDING TUBE WHEN IT BECAME BLOCKED. THEY TRIED TO FLUSH TO UNBLOCK THE MEDICATION AND THEN THE NASOGASTRIC TUBE MADE A BURSTING SOUND AND A HOLE WAS NOTED IN THE TUBE. THERE WAS A DELAY IN PATIENT'S MEDICATIONS, NUTRITION AND HYDRATION. CHALLENGING NASOGASTRIC TUBE PLACEMENTS. PATIENT REQUIRED ADDITIONAL NASOGASTRIC TUBE INSERTIONS PROCEDURES WHICH PATIENT FOUND DISTRESSING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25651171 ↗
  • MalfunctionJun 29, 2026Complete Blockage; Material Rupture

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00512 FOR THE FIRST REPORT. IT WAS REPORTED THAT NURSING STAFF WERE ADMINISTERING MEDICATION THROUGH THE NASOGASTRIC FEEDING TUBE WHEN IT BECAME BLOCKED. THEY TRIED TO FLUSH TO UNBLOCK THE MEDICATION AND THEN THE NASOGASTRIC TUBE MADE A BURSTING SOUND AND A HOLE WAS NOTED IN THE TUBE. THERE WAS A DELAY IN PATIENT'S MEDICATIONS, NUTRITION AND HYDRATION. CHALLENGING NASOGASTRIC TUBE PLACEMENTS. PATIENT REQUIRED ADDITIONAL NASOGASTRIC TUBE INSERTIONS PROCEDURES WHICH PATIENT FOUND DISTRESSING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25651157 ↗
  • MalfunctionMay 12, 2026Complete Blockage

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO (B)(6) FOR THE FIRST REPORT REFER TO (B)(6) FOR THE SECOND REPORT IT WAS REPORTED THAT A NASOGASTRIC FEEDING TUBE BLOCKED, BUT THE PATIENT DIDN'T FLUSH IT OUT AND DIDN'T PUT ANY PRESSURE, SO IT DIDN'T BURST THIS TIME. EVENT DATE UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25154940 ↗
  • MalfunctionMay 12, 2026Complete Blockage; Fracture

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00307 FOR THE FIRST REPORT. REFER TO 9611594-2026-00308 FOR THE SECOND REPORT . IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OCCLUSION WITH A NASOGASTRIC FEEDING TUBE AND UPON ATTEMPTING TO UNBLOCK IT, THE TUBE RUPTURED. THE PATIENT CAME BACK TO THE HOSPITAL AND HAD A NEW ONE INSERTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25154936 ↗
  • MalfunctionMay 12, 2026Material Puncture/Hole

    IT WAS REPORTED THAT A NASOGASTRIC TUBE (NGT) WAS INSERTED AND NOT USED. PATIENT ATTENDED X-RAY FOR PLACEMENT CONFIRMATION. ON RETURN TO THE WARD, THE GUIDEWIRE WAS REMOVED AND FEED STARTED. FEED STARTED COMING OUT OF HOLE IN TUBE BY NOSE. FEED STOPPED AND NGT REMOVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25154843 ↗
  • MalfunctionMay 5, 2026Leak/Splash

    IT WAS REPORTED THAT WARD STAFF INSERTED A NASOGASTRIC TUBE AND THEY DISCOVERED A LEAK NEAR THE FEEDING PORT WHEN FLUSHING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25081159 ↗
  • MalfunctionMay 4, 2026Fluid/Blood Leak

    IT WAS REPORTED THAT A NASOGASTRIC (NG) TUBE WAS INSERTED, AND ITS POSITION CONFIRMED. WHEN FOOD WAS STARTED, THE TUBE LEAKED FROM APPROXIMATELY 1 CM FROM THE PURPLE PORT. A NEW NG TUBE WAS INSERTED FROM A DIFFERENT LOT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25071958 ↗
  • MalfunctionMay 4, 2026Material Puncture/Hole

    IT WAS REPORTED THAT A TUBE HAD A HOLE/DEFECT PROXIMALLY AFTER INSERTION. IT HAD TO BE REPLACED IMMEDIATELY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25071795 ↗
  • MalfunctionMar 30, 2026Material Puncture/Hole

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00152 FOR THE FIRST REPORT REFER TO 9611594-2026-00154 FOR THE THIRD REPORT THE CUSTOMER REPORTED ¿HOLE IN THE TUBE AFTER ADMISSION¿ OCCURRING DURING USE OF A CORFLO NASOGASTRIC FEEDING TUBE. THE TUBE REQUIRED REPLACEMENT. PER ADDITIONAL INFORMATION RECEIVED ON 28-AUG-2025, THE DEFECT WAS DESCRIBED AS A HOLE LOCATED ON THE YELLOW TUBING NEXT TO THE PURPLE CONNECTOR, OCCURRING OUTSIDE OF THE PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24737680 ↗
  • MalfunctionMar 30, 2026Material Puncture/Hole

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2026-00152 FOR THE FIRST REPORT REFER TO 9611594-2026-00153 FOR THE SECOND REPORT. THE CUSTOMER REPORTED ¿HOLE IN THE TUBE AFTER ADMISSION¿ OCCURRING DURING USE OF A CORFLO NASOGASTRIC FEEDING TUBE. THE TUBE REQUIRED REPLACEMENT. PER ADDITIONAL INFORMATION RECEIVED ON 28-AUG-2025, THE DEFECT WAS DESCRIBED AS A HOLE LOCATED ON THE YELLOW TUBING NEXT TO THE PURPLE CONNECTOR, OCCURRING OUTSIDE OF THE PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24735607 ↗
  • MalfunctionMar 30, 2026Material Puncture/Hole

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2026-00153 FOR THE SECOND REPORT REFER TO 9611594-2026-00154 FOR THE THIRD REPORT. THE CUSTOMER REPORTED ¿HOLE IN THE TUBE AFTER ADMISSION¿ OCCURRING DURING USE OF A CORFLO NASOGASTRIC FEEDING TUBE. THE TUBE REQUIRED REPLACEMENT. PER ADDITIONAL INFORMATION RECEIVED ON 28-AUG-2025, THE DEFECT WAS DESCRIBED AS A HOLE LOCATED ON THE YELLOW TUBING NEXT TO THE PURPLE CONNECTOR, OCCURRING OUTSIDE OF THE PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24735495 ↗
  • MalfunctionFeb 4, 2026Leak/Splash; Material Puncture/Hole

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00035 FOR THE SECOND REPORT. IT WAS REPORTED, AFTER NASOGASTRIC (NG) TUBE PLACEMENT WAS CONFIRMED, ENTERAL FEEDING WAS INITIATED. SHORTLY AFTERWARD, A SMALL HOLE WAS IDENTIFIED NEAR THE CONNECTION POINT BETWEEN THE FEED LINE AND THE NG TUBE, RESULTING IN FEED LEAKING ONTO THE PATIENT. FEEDING WAS STOPPED IMMEDIATELY, AND THE NURSE IN CHARGE AND THE MEDICAL TEAM WERE NOTIFIED. A NEW NG TUBE WAS INSERTED, AND THE PATIENT WAS AWAITING A CONFIRMATORY CHEST X-RAY. PER ADDITIONAL INFORMATION RECEIVED ON 13JAN2026, THE PATIENT WAS RECEIVING CONTINUOUS FEEDINGS THROUGH THE NG TUBE. NO BLENDED FEEDS OR THICK-CONSISTENCY FORMULAS WERE ADMINISTERED. THE TUBE MAY HAVE BEEN USED FOR ORAL AND/OR CRUSHED MEDICATIONS. THE TUBE WAS FLUSHED EACH TIME MEDICATIONS OR FEEDINGS WERE ADMINISTERED; THE TUBE HAD BEEN IN PLACE FOR ONLY FOUR HOURS. A 20 ML OR 50 ML SYRINGE WAS USED FOR FLUSHING. THERE WAS NO HISTORY OF CLOGGING PRIOR TO THE RUPTURE. FLUSHING WAS PERFORMED MANUALLY USING A SYRINGE. A 20 ML OR 50 ML SYRINGE WAS

    Patient problems: Feeding Problem

    MAUDE report 24259124 ↗
  • MalfunctionFeb 4, 2026Leak/Splash; Material Puncture/Hole

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00034 FOR THE FIRST REPORT IT WAS REPORTED, AN NASOGASTRIC (NG) TUBE WAS FOUND TO BE LEAKING. UPON RETURN OF THE NG ASPIRATE, A LEAK WAS OBSERVED WITHIN THE PATIENT¿S NOSTRIL, APPROXIMATELY 2 CM INWARD FROM THE TUBE HOLDER. THE LOCATION OF THE SPLIT SUGGESTS IT IS UNLIKELY TO HAVE BEEN CAUSED BY HANDLING. THE TUBE HAD BEEN IN SITU FOR ONLY 24 HOURS, AND THE PATIENT WAS TOO CLINICALLY UNSTABLE TO MOBILIZE OR REPOSITION IN BED. PER ADDITIONAL INFORMATION RECEIVED ON 13JAN2026, THE PATIENT WAS RECEIVING CONTINUOUS FEEDINGS THROUGH THE NG TUBE. NO BLENDED FEEDS OR THICK-CONSISTENCY FORMULAS WERE ADMINISTERED. THE TUBE MAY HAVE BEEN USED FOR ORAL AND/OR CRUSHED MEDICATIONS. THE TUBE WAS FLUSHED EACH TIME MEDICATIONS OR FEEDINGS WERE ADMINISTERED; THE TUBE HAD BEEN IN PLACE FOR ONLY FOUR HOURS. A 20 ML OR 50 ML SYRINGE WAS USED FOR FLUSHING. THERE WAS NO HISTORY OF CLOGGING PRIOR TO THE RUPTURE. FLUSHING WAS PERFORMED MANUALLY USING A SYRINGE. A 20 ML OR 50 ML SYRINGE WAS USED FOR MANUAL FLUSHING. PUMP US

    Patient problems: Feeding Problem

    MAUDE report 24259123 ↗
  • MalfunctionJan 7, 2026Leak/Splash; Material Puncture/Hole

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00004 FOR THE FIRST REPORT. IT WAS REPORTED, ¿NEW TUBE INSERTED AND ATTENDED FOR X-RAY. X-RAY DONE AT 12:27. TUBE USED AROUND 2 PM. WATER NOTED TO BE LEAKING THROUGH HOLE BENEATH CONNECTOR. TUBE REMOVED AND REPLACEMENT ARRANGED.¿ NO INJURY OCCURRED TO THE PATIENT.

    Patient problems: Feeding Problem

    MAUDE report 23989254 ↗
  • MalfunctionJan 7, 2026Leak/Splash; Material Puncture/Hole

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00005 FOR THE SECOND REPORT. IT WAS REPORTED, ¿NASOGASTRIC TUBE (NGT) INSERTED AROUND 11 PM ON (B)(6) 2025. X-RAY DONE TO CONFIRM POSITION AT 00:53. FED THROUGH TUBE BETWEEN 01:04 AND0 5:12. FEED STOPPED AND TUBE REMOVED AS FEED NOTED TO BE LEAKING THROUGH HOLE BENEATH CONNECTOR.¿ NO INJURY OCCURRED TO THE PATIENT.

    Patient problems: Feeding Problem

    MAUDE report 23988800 ↗
  • MalfunctionOct 17, 2025Material Rupture; Material Rupture

    IT WAS REPORTED THAT A NASOGASTRIC (NGT) WAS INSERTED IN A PATIENT IN THE INTENSIVE CARE UNIT (ICU). AFTER SATISFACTORY TUBE PLACEMENT WAS CONFIRMED, THE FEED WAS COMMENCED. ONCE THE FEED COMMENCED IT FLOWED OUT OF THE PERFORATION SITE. THE FEED WAS IMMEDIATELY HELD AND NGT REMOVED. THE PREVIOUS DAY ON ((B)(6) 2025) WHEN THE SAME PATIENT WAS BEING FED VIA A NGT (PLACED ON (B)(6) 2025), FEED FLOWED OUT OF THEIR NOSE AND MOUTH. AT THE TIME IT WAS THOUGHT THAT THIS WAS DUE TO THE PATIENTS COMPLEX MEDICAL ISSUES BUT PERHAPS THERE WAS A PERFORATION IN THAT NGT TOO. ADDITIONAL INFORMATION RECEIVED ON 22-SEP-2025 STATING "NGT PLACED IN PATIENT BUT PURPLE "Y" PORT AT TOP DISLODGED. (SECOND) NGT POSITION CONFIRMED AND FEED WAS COMMENCED VIA FEEDING PUMP. IMMEDIATELY FEED SPILLED OUT OF TUBE THROUGH PERFORATION IN TUBE. FEED IMMEDIATELY STOPPED (AND) NGT REMOVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23328445 ↗
  • MalfunctionSep 10, 2025Break; Break

    IT WAS REPORTED THE "BURST CORFLO TUBE." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 14-AUG-2025 NOTED, "THE INCIDENT OCCURRED ON (B)(6) WHEN THE PATIENT HAD A CT [COMPUTED TOMOGRAPHY] SCAN AND THE RADIOLOGIST NOTED THERE TO BE A 6 CM SEGMENT OF RETAINED TUBING WITHIN THE DUODENUM SUGGESTIVE OF BEING THE TIP OF AN NG TUBE. ON REMOVAL OF THE NG TUBE THE TIP WAS MISSING AND AROUND 6-8 CM LOST OFF THE END. THERE IS DAMAGE/FRIABLE SECTION OF THE NG [NASOGASTRIC] TUBE." "THE PRODUCT HAD BEEN IN USE SINCE (B)(6) 2025 (25 DAYS). AT THE MOMENT THE RETAINED FB REMAINS IN SITU WITH ENDOSCOPY ADVICE THAT IT MAY BE PASSED IN THE FECES. THIS WILL NEED CONFIRMING AND IT IS POSSIBLE THAT THE PATIENT MAY NEED REMOVAL OF THE TIP AT SOME STAGE." ADDITIONAL INFORMATION RECEIVED 26-AUG-2025 STATED THE DEVICE WAS IN USE FOR CONTINUOUS FEEDING. THERE WERE NO BLENDED FEEDS AND/OR THICK CONSISTENCY FORMULAS USED IN THE DEVICE. ORAL AND/OR CRUSHED MEDICATIONS WERE USED IN THE DEVICE. THE DEVICE WAS FLUSHED EVERY TIME AN ORAL MEDICATION WAS GIVEN (ON 8 DIFFERENT ORAL MEDICATIONS EACH UP TO 4 TIMES A DAY). THE CLINICIANS USED 50ML OR 20MOL SYRINGES TO GIVE MEDICATION/ WATER FLUSHES. THERE W

    Patient problems: Foreign Body In Patient

    MAUDE report 23015148 ↗
  • MalfunctionApr 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED, ¿FINE BORE NG [NASOGASTRIC] THAT SPLIT RESULTING IN A PATIENT ASPIRATION.¿ PER ADDITIONAL INFORMATION RECEIVED ON 07APR2025, ¿FINE BORE NG INSERTED ON (B)(6) 2025. FEED SUCTIONED FROM SUBGLOTTIC AIRWAY ON (B)(6) 2025. NG REMOVED AND RE-SITED, INCIDENT FORM COMPLETED. NOTED BULGE/SPIT IN NG TUBE.¿ IT WAS ADDITIONALLY REPORTED, ¿THE TUBE SPLIT AT 45CM. DUE TO THE COMPLEXITY OF THE PATIENT, IT IS DIFFICULT TO ASCERTAIN IF THE PATIENT'S RECURRENT HAP'S WERE SECONDARY TO THE SPLIT IN THE TUBE, NONETHELESS IT IS A POSSIBILITY THAT IT MAY HAVE CONTRIBUTED. PATIENT RIP ON (B)(6) 2025. PATIENT DEATH NOT DUE TO PRODUCT DEFECT. CORONERS IN PROGRESS.¿

    Patient problems: Aspiration/Inhalation

    MAUDE report 21933906 ↗
  • MalfunctionNov 8, 2024Break; Break

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2024-00246 FOR THE SECOND EVENT. IT WAS REPORTED THE NASOJEJUNAL TUBE (NJT) RUPTURED 15CM FROM THE END NECESSITATING AN UNPLANNED SURGICAL PROCEDURE TO RECOVER THE NJT. "THE PATIENT HAD STOPPED TOLERATING FEED, UPON X-RAY REALIZED IT HAD SEPARATED." THE PATIENT "HAD TO GO BACK UNDER ANESTHETIC FOR PROCEDURE TO RETRIEVE THE TUBE." THE PATIENT IS REPORTED TO BE STABLE.

    Patient problems: Foreign Body In Patient

    MAUDE report 20646396 ↗
  • MalfunctionNov 8, 2024Fracture; Fracture

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2024-00245 FOR THE FIRST EVENT. IT WAS REPORTED THE NASOJEJUNAL TUBE (NJT) RUPTURED 15CM FROM THE END NECESSITATING REPLACEMENT OF THE DEVICE THAT WAS FRACTURED ON INITIAL USE. THE PATIENT IS REPORTED TO BE STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20645022 ↗
  • MalfunctionAug 27, 2024Break; Break

    IT WAS REPORTED, NASOGASTRIC (NG) TUBE BROKE WHILE USED ON A PATIENT. PATIENT STARTED COUGHING AND RETCHING. THE LENGTH OF THE TUBE CHANGED BY 15CM. PER ADDITIONAL INFORMATION RECEIVED ON 12AUG2024, THE PATIENT IS IMPROVING ON WARD. THERE WAS NO IMPACT FROM THE NG TUBE THAT REMAINED INSIDE THE ESOPHAGUS. IT WAS REVIEWED BY THE GASTROENTEROLOGIST AND THE PLAN IS TO WAIT FOR TUBE TO PASS NATURALLY.

    Patient problems: Cough; Foreign Body In Patient; Vomiting

    MAUDE report 20075023 ↗
  • MalfunctionMay 23, 2024Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

    IT WAS REPORTED, ¿FEED NOTED TO BE COMING FROM TRACHEOSTOMY SITE, UPON INVESTIGATING IT WAS NOTICED A PUNCTURE/CUT INTO THE NASOGASTRIC FEEDING TUBE. PATIENT WHO HAD MAX-FAX SURGERY, TRACHEOSTOMY AND NASOGASTRIC TUBE INSERTION FOR FEEDING DONE ON THE (B)(6) 2024. FEEDING TUBE WAS CONFIRMED BY CHEST X-RAY AND WAS DETERMINED SAFE TO USE BY DOCTOR. ONCE FEEDING STARTED, THE FEED WAS NOTED TO BE COMING FROM THE TRACHEOSTOMY SITE. PATIENT AT RISK FOR ASPIRATION OF FEED INTO THE LUNGS.¿ IT WAS ADDITIONALLY REPORTED, ¿EQUIPMENT REMOVED FROM PATIENT. EQUIPMENT QUARANTINED. CHEST X-RAY PERFORMED TO PATIENT. TRACHEAL CUFF KEPT INFLATED AND PATIENT WAS NURSED IN AN UPRIGHT POSITION. STARTED ON ANTIBIOTICS. PATIENT WAS INFORMED AND RE-ASSURED. MEDICAL DECISION TO START PARENTERAL NUTRITION INSTEAD OF ENTERAL NUTRITION DUE TO RISK RELATED TO NEW NASOGASTRIC INSERTION.¿

    Patient problems: Cough; Feeding Problem

    MAUDE report 19383073 ↗
  • InjuryMar 30, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE NURSE FLUSHED THE NASOGASTRIC (NG) TUBE UNDER GRAVITY AND THE PATIENT STARTED VIOLENTLY COUGHING WATERY SPUTUM OUT OF HIS TRACHEOSTOMY. IT APPEARED THAT HE MAY BE ASPIRATING ON THE WATER, SO THE NURSE IMMEDIATELY STOPPED TO INVESTIGATE. WHEN THE NG TUBE WAS SUBSEQUENTLY REMOVED, A 2CM LENGTH HAD DILATED AND SPLIT AROUND THE 45CM MARK. IT IS UNCLEAR WHEN THIS HAPPENED AND HOW MUCH FEED OR FLUID HAD LEAKED INTO HIS LUNGS. THE PATIENT REMAINED UNWELL 24 HOURS LATER AND NEEDED HIGHER O2 REQUIREMENTS. MEDICAL TREATMENT REPORTED INCLUDES ANTIBIOTICS AND CHEST PHYSIO. THE TUBE HAD BEEN IN USE FOR 28 DAYS. PER ADDITIONAL INFORMATION RECEIVED ON 10MAR2023, ¿THE PATIENT REMAINS UNWELL WITH A LOWER RESPIRATORY TRACT INFECTION FOR WHICH HE¿S PRESCRIBED ANTIBIOTICS.¿ PER ADDITIONAL INFORMATION RECEIVED ON 20MAR2023, ¿HE [THE PATIENT] SEEMS TO HAVE DETERIORATED CLINICALLY IN THE LAST FEW DAYS WITH ANOTHER CHEST INFECTION. HE¿S NOW ON END OF LIFE CARE.¿

    Patient problems: Aspiration/Inhalation; Cough; Respiratory Tract Infection

    MAUDE report 16647553 ↗

Other Tubes, gastrointestinal (and accessories) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.